| 1. |
- Ding, Wern Yew, et al.
(författare)
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Impact of diabetes on the management and outcomes in atrial fibrillation : an analysis from the ESC-EHRA EORP-AF Long-Term General Registry
- 2022
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Ingår i: European journal of internal medicine. - : Elsevier. - 0953-6205 .- 1879-0828. ; 103, s. 41-49
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Tidskriftsartikel (refereegranskat)abstract
- Background: The prevalence of atrial fibrillation(AF) and diabetes mellitus is rising to epidemic proportions. We aimed to assess the impact of diabetes on the management and outcomes of patients with AF. Methods: The EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. Outcomes of interest were as follows: i)rhythm control interventions; ii)quality of life; iii)healthcare resource utilisation; and iv)major adverse events. Results: Of 11,028 patients with AF, the median age was 71 (63-77) years and 2537 (23.0%) had diabetes. Median follow-up was 24 months. Diabetes was related to increased use of anticoagulation but less rhythm control interventions. Using multivariable analysis, at 2-year follow-up, patients with diabetes were associated with greater levels of anxiety (p = 0.038) compared to those without diabetes. Overall, diabetes was associated with worse health during follow-up, as indicated by Health Utility Score and Visual Analogue Scale. Healthcare resource utilisation was greater with diabetes in terms of length of hospital stay (8.1 (+/- 8.2) vs. 6.1 (+/- 6.7) days); cardiology and internal medicine/general practitioner visits; and emergency room admissions. Diabetes was an independent risk factor of major adverse cardiovascular event (MACE; HR 1.26 [95% CI, 1.04-1.52]), all-cause mortality (HR 1.28 [95% CI, 1.08-1.52]), and cardiovascular mortality (HR 1.41 [95% CI, 1.09-1.83]). Conclusion: In this contemporary AF cohort, diabetes was present in 1 in 4 patients and it served as an independent risk factor for reduced quality of life, greater healthcare resource utilisation and excess MACE, all-cause mortality and cardiovascular mortality. There was increased use of anticoagulation therapy in diabetes but with less rhythm control interventions.
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| 2. |
- Johansson, Birgitta, et al.
(författare)
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Atrial function after left atrial epicardial cryoablation for atrial fibrillation in patients undergoing mitral valve surgery
- 2012
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Ingår i: Journal of Interventional Cardiac Electrophysiology. - : Springer Science+Business Media B.V.. - 1383-875X .- 1572-8595. ; 33:1, s. 85-91
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To explore the effects on atrial and ventricular function of restoring sinus rhythm (SR) after epicardial cryoablation and closure of the left atrial appendage (LAA) in patients with mitral valve disease and atrial fibrillation (AF) undergoing surgery.METHODS: Sixty-five patients with permanent AF were randomized to mitral valve surgery combined with left atrial epicardial cryoablation and LAA closure (ABL group, n = 30) or to mitral valve surgery alone (control group, n = 35). Two-dimensional and Doppler echocardiography were performed before and 6 months after surgery.RESULTS: At 6 months, 73% of the patients in the ABL group and 46% of the controls were in SR. Patients in SR at 6 months had a reduction in their left ventricular diastolic diameter while the left ventricular ejection fraction was unchanged. In patients remaining in AF, the left ventricular ejection fraction was lower than at baseline. The left atrial diastolic volume was reduced after surgery, more in patients with SR than AF. In patients in SR, the peak velocity during the atrial contraction and the reservoir function were lower in the ABL group than in the control group.CONCLUSIONS: In patients in SR, signs of atrial dysfunction were observed in the ABL but not the control group. Atrial dysfunction may have existed before surgery, but the difference between the groups implies that the cryoablation procedure and/or closure of the LAA might have contributed.
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| 3. |
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| 4. |
- Blomström-Lundqvist, Carina, 1954-, et al.
(författare)
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European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections : endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)
- 2020
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 22:4, s. 515-516ag
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Tidskriftsartikel (refereegranskat)abstract
- Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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| 5. |
- Ding, Wern Yew, et al.
(författare)
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Impact of ABC (Atrial Fibrillation Better Care) pathway adherence in high-risk subgroups with atrial fibrillation : A report from the ESC-EHRA EORP-AF long-term general registry
- 2023
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Ingår i: European journal of internal medicine. - : Elsevier. - 0953-6205 .- 1879-0828. ; 107, s. 60-65
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Tidskriftsartikel (refereegranskat)abstract
- Background: Effects of Atrial Fibrillation Better Care (ABC) adherence among high-risk atrial fibrillation (AF) subgroups remains unknown. We aimed to evaluate the impact of ABC adherence on clinical outcomes in these high-risk patients.Methods: EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. High-risk patients were defined as those with either CKD (eGFR <60 mL/min/1.73m2), elderly patients (>= 75 years) or prior thromboembolism. Primary outcome was a composite event of all-cause death, thromboembolism and acute coronary syndrome.Results: 6646 patients with AF were screened (median age was 70 [IQR 61 - 77] years; 40.2% females). There were 3304 (54.2%) patients with either CKD (n = 1750), older age (n = 2236) or prior thromboembolism (n = 728). Among these, 924 (28.0%) were managed as adherent to ABC. At 2-year follow-up, 966 (14.5%) patients reported the primary outcome. The incidence of the primary outcome was significantly lower in high-risk patients managed as adherent to ABC pathway (IRR 0.53 [95%CI, 0.43 - 0.64]). Consistent results were obtained in the individual subgroups. Using multivariable Cox proportional hazards analysis, ABC adherence in the high-risk cohort was independently associated with a lower risk of the primary outcome (aHR 0.64 [95%CI, 0.51 - 0.80]), as well as in the CKD (aHR 0.51 [95%CI, 0.37 - 0.70]) and elderly subgroups (aHR 0.69 [95%CI, 0.53 - 0.90]). Overall, there was greater reduction in the risk of primary outcome as more ABC criteria were fulfilled, both in the overall high-risk patients (aHR 0.39 [95%CI, 0.25 - 0.61]), as well as in the individual subgroups.Conclusion: In a large, contemporary cohort of patients with AF, we demonstrate that adherence to the ABC pathway was associated with a significant benefit among high-risk patients with either CKD, advanced age (>75 years old) or prior thromboembolism.
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| 6. |
- Lloyd, Michael S., et al.
(författare)
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Design and rationale of the MODULAR ATP global clinical trial : A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator
- 2023
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Ingår i: HEART RHYTHM O2. - : Elsevier. - 2666-5018. ; 4:7, s. 448-456
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support.OBJECTIVE: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented.METHODS: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER (TM) Modular Pacing System and EMBLEM (TM) Subcutaneous ICD to Communicate Antitachycardia Pacing) is amulticenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly.85% at 2 years.RESULTS: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described.CONCLUSION: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.
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| 7. |
- Ahmed, Fozia Z., et al.
(författare)
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Use of healthcare claims to validate the Prevention of Arrhythmia Device Infection Trial cardiac implantable electronic device infection risk score
- 2021
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 23:9, s. 1446-1455
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Tidskriftsartikel (refereegranskat)abstract
- AIM: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims.METHODS AND RESULTS: Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76.CONCLUSION: The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score.
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| 8. |
- Aktaa, Suleman, et al.
(författare)
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European Society of Cardiology Quality Indicators for the care and outcomes of cardiac pacing : developed by the Working Group for Cardiac Pacing Quality Indicators in collaboration with the European Heart Rhythm Association of the European Society of Cardiology
- 2022
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 24:1, s. 165-172
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing.METHODS AND RESULTS: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy.CONCLUSION: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.
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| 9. |
- Anselmino, Matteo, et al.
(författare)
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Atrial fibrillation ablation long-term ESC-EHRA EORP AFA LT registry : in-hospital and 1-year follow-up findings in Italy
- 2020
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Ingår i: Journal of Cardiovascular Medicine. - : Ovid Technologies (Wolters Kluwer Health). - 1558-2027 .- 1558-2035. ; 21:10, s. 740-748
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To report the Italian data deriving from the European Society of Cardiology-EURObservational Research Program atrial fibrillation ablation long-term registry.Methods and results: Ten Italian centers enrolled up to 50 consecutive patients undergoing atrial fibrillation ablation. Of the 318 patients included, 5 (1.6%) did not undergo catheter ablation, 1 had ablation partially done and 62 were lost at 1-year follow-up. Women were less represented (23.6%) and the median age was 60.0 years. A total of 195 patients (62.3%) suffered paroxysmal atrial fibrillation, whereas only 9 (2.9%) had long-standing persistent atrial fibrillation. Most Italian patients (92.3%) were symptomatic but suffering fewer symptomatic events than patients enrolled in other countries (median of two events in the month preceding the ablation vs. three, respectively; P<0.0001). The main finding of the study is that the success rate at 1 year, with and without antiarrhythmic drugs, was 76.4%, consistently with other participating countries (73.4%). This result was obtained however, with a significantly lower prevalence of 1-year adverse events (7.3 vs. 16.6%, P<0.0001). Procedure duration and fluoroscopy total time resulted as being shorter in Italy (145 vs. 160, P=0.0005 and 16.9 vs. 20.0 min, P=0.0018, respectively); however, the radiation dose per BSA was greater (37.5 vs. 26.0mGy/cm(2), P=0.0022).Conclusion: The demographic characteristics of patients undergoing atrial fibrillation ablation are similar to those reported in other countries. The success rate in Italy is consistent with those in other countries, whereas the complications rate is lower.
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| 10. |
- Arbelo, Elena, et al.
(författare)
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Contemporary management of patients undergoing atrial fibrillation ablation : in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry
- 2017
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Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 38:17, s. 1303-1316
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Tidskriftsartikel (refereegranskat)abstract
- Aims The ESC-EHRA Atrial Fibrillation Ablation Long-Term registry is a prospective, multinational study that aims at providing an accurate picture of contemporary real-world ablation for atrial fibrillation (AFib) and its outcome. Methods and results A total of 104 centres in 27 European countries participated and were asked to enrol 20-50 consecutive patients scheduled for first and re-do AFib ablation. Pre-procedural, procedural and 1-year follow-up data were captured on a web-based electronic case record form. Overall, 3630 patients were included, of which 3593 underwent an AFib ablation (98.9%). Median age was 59 years and 32.4% patients had lone atrial fibrillation. Pulmonary vein isolation was attempted in 98.8% of patients and achieved in 95-97%. AFib-related symptoms were present in 97%. Inhospital complications occurred in 7.8% and one patient died due to an atrioesophageal fistula. One-year follow-up was performed in 3180 (88.6%) at a median of 12.4 months (11.9-13.4) after ablation: 52.8% by clinical visit, 44.2% by telephone contact and 3.0% by contact with the general practitioner. At 12-months, the success rate with or without antiarrhythmic drugs (AADs) was 73.6%. A significant portion (46%) was still on AADs. Late complications included 14 additional deaths (4 cardiac, 4 vascular, 6 other causes) and 333 (10.7%) other complications. Conclusion AFib ablation in clinical practice is mostly performed in symptomatic, relatively young and otherwise healthy patients. Overall success rate is satisfactory, but complication rate remains considerable and a significant portion of patients remain on AADs. Monitoring after ablation shows wide variations. Antithrombotic treatment after ablation shows insufficient guideline-adherence.
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